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Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation

NCT02909465 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2017-11-07

No results posted yet for this study

Summary

Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure.

Conditions

  • Ketamine Induced Agitation

Interventions

DRUG

Midazolam

Using Midazolam as a premedication for reducing ketamine-induced agitation

DRUG

Haloperidol

Using Haloperidol as a premedication for reducing ketamine-induced agitation

DRUG

placebo

distilled water

DRUG

Ketamine

Ketamine is routinely used for all procedural sedation in the patients.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-04-30
Completion
2017-07-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02909465 on ClinicalTrials.gov